Examining the Effect of Exogenous Ketone Supplementation on Glucose Control in Type 2 Diabetes

NCT ID: NCT05155410

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2023-02-03

Brief Summary

Ketone bodies are a fuel source and signaling molecule that are produced by the body during prolonged fasting or if an individuals consistently eats a low-carbohydrate "keto" diet. Blood ketones can be used as a source of energy by the body, but they may also act as signals that impact the functioning of different cells in the body. Recently, the availability of ketone supplements that can be taken orally allows for raising blood ketones without having to fast or eat a "keto" diet. The investigators' studies and those of other researchers have shown that ketone supplementation can lower blood sugar without having to make any other dietary changes. Oral ingestion of ketones may therefore be an effective strategy to improve blood sugar control and influence how cells function.

The main objective of this study is to determine if consuming a ketone supplement 3 times per day (before meals) for 14 days lowers blood sugar and impacts how the body's cells function. The results of this study will be used to guide future recommendations on the utility of ketone supplements for improving health in individuals with, or at elevated risk of, type 2 diabetes.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental

Participants will consume 15 g of an active oral exogenous ketone monoester supplement 15 minutes prior to each meal of the day for a 14-day period.

Pre-intervention (baseline) and post-intervention measurements will be obtained before and immediately after the 14-day period.

All meals will be provided throughout the supplementation period Participants will wear a continuous glucose monitor for the first 10 consecutive days during the supplementation period.

Group Type: EXPERIMENTAL

Exogenous Ketone Monoester

Intervention Type: DIETARY_SUPPLEMENT

Participants will consume 15g of the oral ketone monoester supplement 15 minutes prior to each meal of the day for 14 days. All meals will be provided throughout the 14-day supplementation period.

Placebo

Participants will consume a flavor-matched placebo drink and undergo the same procedures described in the Experimental Arm

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants will consume an equivalent volume (30ml) of the active intervention supplement 15 minutes prior to each meal for 14 days. All meals will be provided throughout the 14-day placebo supplementation period.

Interventions

Exogenous Ketone Monoester

Participants will consume 15g of the oral ketone monoester supplement 15 minutes prior to each meal of the day for 14 days. All meals will be provided throughout the 14-day supplementation period.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Participants will consume an equivalent volume (30ml) of the active intervention supplement 15 minutes prior to each meal for 14 days. All meals will be provided throughout the 14-day placebo supplementation period.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

KetoneAid KE4 Ketone Ester, D-β-hydroxybutyrate-R 1,3-Butanediol; Flavor- and volume-matched placebo supplement

Eligibility Criteria

Inclusion Criteria

• Have a type 2 diabetes diagnosis from a physician
• Have stable use of glucose-lowering medications for at least 3 months

Exclusion Criteria

• Are a competitively trained endurance athlete
• Are actively attempting to gain or lose weight
• Have a history of mental illness or existing neurological disease(s), cardiovascular events (i.e., heart attack, stroke) in the last 2 years
• Have hypoglycemia, irritable bowel syndrome or inflammatory bowel disease
• Are currently using insulin or SGLT2 inhibitors
• Are using more than 2 classes of glucose-lowering medication
• Are currently following a ketogenic diet or taking ketone supplements
• Are unable to commit for a 29-day trial
• Are unable to follow a controlled diet

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Little

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Little, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia- Okanagan

Locations

University of British Columbia Okanagan

Kelowna, British Columbia, Canada

Countries

Canada

References

Baranowski BJ, Oliveira BF, Falkenhain K, Little JP, Mohammad A, Beaudette SM, Finch MS, Caldwell HG, Neudorf H, MacPherson REK, Walsh JJ. Effect of exogenous beta-hydroxybutyrate on BDNF signaling, cognition, and amyloid precursor protein processing in humans with T2D and insulin-resistant rodents. Am J Physiol Cell Physiol. 2025 Feb 1;328(2):C541-C556. doi: 10.1152/ajpcell.00867.2024. Epub 2025 Jan 13.

Reference Type: DERIVED

PMID: 39804761 (View on PubMed)

Other Identifiers

H21-01762

Identifier Type: -

Identifier Source: org_study_id